Advisory Committee on Dangerous Pathogens

1 Advisory Committee ON Dangerous Pathogens Advice on Experimental working with Influenza Viruses of Pandemic Potential Contents: Introduction Purpose and Scope Current classification and guidance Recommendations for laboratories deliberately working with influenza viruses Recommendations for Diagnostic work Use of microbiological safety cabinets Contacts Annex 1 - Guidance on the application of the Specified Animal Pathogens Order 2008 (SAPO) to work with avian influenza viruses - Additional guidance notes Introduction 1.

2 This document replaces the ACDP 2005 publication Advice on Working with Influenza Viruses , and provides new guidance on local risk assessment requirements and commensurate laboratory containment for work with influenza viruses of pandemic potential. Purpose and scope 2. The purpose of this document is to provide guidance on appropriate containment measures to protect both human and animal health and the environment to those working with influenza viruses of pandemic potential in research laboratories or in animal experimentation work or diagnostic work.

3 The recommendations for diagnostic work are provided in a separate section within the document. The guidance recognises the different risks to health presented by influenza strains of pandemic potential. 3. The information in this document is intended to be used as a framework to help those responsible for risk assessment in laboratories to reflect the local risks and to provide a consistent, transparent and unified approach to containment of these influenza viruses.

4 Current classification and guidance 4. The Approved List of Biological Agents (published in 2004) classifies influenza types A, B and C as Hazard Group 2 agents. ACDP agrees that though most influenza viruses from human sources may be safely handled at containment level 2 (CL2) there are circumstances and activities when a higher containment level is required to protect human and animal health. 5. The Control of Substances Hazardous to Health Regulations 2002 (COSHH) (Schedule 3 para 3) requires that, where an agent with an approved ACDP classification is used, and the risk of infection is different to that expected, a local reclassification must be carried out by the employer.

5 Suitable containment and controls must then be selected accordingly, in line with a local risk assessment of the activity being undertaken and in consultation with HSE. That risk assessment must address, amongst other factors, the immune status of those who will be undertaking the work, taking into account exposure to circulating viruses and any relevant vaccination history, and the availability of vaccines and effective antiviral treatment. 6.

6 Certain influenza virus strains are subject to control under animal health legislation, and specific laboratory containment measures may be required in accordance with a licence issued by DEFRA under the Specified Animal Pathogens Order 2008 (SAPO). This Order may be found at: and more information from Defra is available at: 7. Laboratory work involving the genetic modification of influenza viruses is currently subject to the Genetically Modified Organisms (Contained Use) Regulations 2000 as amended.

7 For further information on the requirements of these regulations see 8. It is also a requirement under the Control of Substances Hazardous to Health regulations that the Health and Safety Executive (HSE) be notified of any: o first use of a biological agent (Hazard Group 2, 3 or 4) at a particular premises; and o subsequent use of any agent listed in Part V of Schedule 3 of COSHH (as amended) Further information about the notification process can be found at: 9.

8 The Regulations and arrangements referred to in paragraphs 3 6 above are currently under [legislative reform]. However, similar requirements for notification and for local risk assessment arise under a new single regulatory framework being prepared, for human and animal Pathogens and genetically modified organisms (due to be implemented in 2011). Recommendations for laboratories deliberately working with influenza viruses 10. These recommendations apply to both laboratory research and animal experimentation, but exclude diagnostic work (see advice in paragraph 11).

9 It is essential that the local risk assessment reflects the inherently unpredictable nature of animal work, especially that involving larger animals. Though local risk assessment will indicate that most influenza viruses from human sources may be safely handled at CL2, it is recommended that higher containment level measures be applied when working with the following viruses, subject to local risk assessment. Viruses that should NOT be handled at containment level 2 a.

10 Viruses potentially highly pathogenic for birds: H5 and H7 isolated from human subjects or from animals should be handled under the appropriate SAPO containment level ( SAPO4) and the hazard they pose to human health should also be evaluated, even if there is no, or limited, evidence of human to human transmission (as for H5N1 strains from human cases). H5 and H7 viruses should thus be handled as though they are highly pathogenic for birds (SAPO4) and for humans (human hazard group 3) until there is evidence to the contrary.